The purpose of this study is to evaluate whether zirconium Zr 89 crefmirlimab berdoxam (other names 89Zr-crefmirlimab berdoxam, 89Zr-Df-crefmirlimab, 89Zr-Df-IAB22M2C) PET/CT can predict the response of advanced or metastatic melanoma, Merkel cell carcinoma, renal cell carcinoma, or non-small cell lung cancer tumors to immuno-oncology therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
70
Up to three zirconium Zr 89 crefmirlimab berdoxam PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion or slow bolus injection as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second zirconium Zr 89 crefmirlimab berdoxam administration and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third zirconium Zr 89 crefmirlimab berdoxam PET scan at the principal investigator's (PI's) discretion.
CARTI Cancer Center
Little Rock, Arkansas, United States
City of Hope
Duarte, California, United States
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 tomography/computed tomography (PET/CT)
Best overall response (BOR) assessed by conventional imaging CT and/or MRI using RECIST 1.1 from 3 (or up to 3) consecutive imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
Time frame: Baseline to at least 24 or 27 weeks after the start of IOT, depending on treatment schedule.
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI)
Largest measured difference from baseline in the lesion major axis from three (or up to three) consecutive standard of care imaging assessments (CT and/or MRI) following onset of immuno-oncology treatment.
Time frame: Baseline to at least 24 or 27 weeks after the start IOT, depending on treatment schedule.
Incidence and severity of AEs
Incidence and severity of AEs
Time frame: Up to 48 weeks or end of treatment.
Incidence and severity of infusion or injection reactions
Incidence and severity of infusion or injection reactions reported during or shortly after administration of the investigational product.
Time frame: 33 days post infusion
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
Incidence of withdrawal from scanning protocol due to zirconium Zr 89 crefmirlimab berdoxam related AEs
Time frame: Up to 48 weeks or end of treatment
12-lead ECG ventricular rate (bpm)
Ventricular rate (bpm) will be recorded from the 12-lead ECG
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Providence Saint John's Cancer Institute
Santa Monica, California, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
UT Southwestern Medical Center
Dallas, Texas, United States
University of Washington
Seattle, Washington, United States
Macquarie University Hospital
Macquarie Park, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Olivia Newton-John Cancer Research Insititute
Heidelberg, Victoria, Australia
...and 6 more locations
Time frame: baseline to 48 weeks or end of study
12-lead ECG PR interval (msec)
PR interval (msec) will be recorded from the 12-lead ECG
Time frame: baseline to 48 weeks or end of study
12-lead ECG QRS interval (msec)
QRS interval (msec) will be recorded from the 12-lead ECG
Time frame: baseline to 48 weeks or end of study
12-lead ECG QT interval (msec)
QT interval (msec) will be recorded from the 12-lead ECG
Time frame: baseline to 48 weeks or end of study
12-lead ECG QTc interval (msec)
QTc interval (msec) will be recorded from the 12-lead ECG
Time frame: baseline to 48 weeks or end of study
12-lead ECG Overall Result
Investigator's overall assessment of the ECG reading will be recorded as normal or abnormal. If abnormal, as either "not clinically significant" or "clinically significant"
Time frame: baseline to 48 weeks or end of study
Anti-drug antibody
Detection of anti-drug antibodies
Time frame: baseline to 48 weeks or end of study
Change in blood AST levels (U/L) from baseline.
Blood AST levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood ALT levels (U/L) from baseline.
Blood ALT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood ALP levels (U/L) from baseline.
Blood ALP levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood bilirubin levels (mg/dL) from baseline.
Blood bilirubin levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood LDH levels (U/L) from baseline.
Blood LDH levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood BUN levels (mg/dL) from baseline.
Blood BUN levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood GGT levels (U/L) from baseline.
Blood GGT levels (U/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in serum creatinine levels (mg/dL) from baseline.
Serum creatinine levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood uric acid levels (mg/dL) from baseline.
Blood uric acid levels (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood sodium levels (mmol/L) from baseline.
Blood sodium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood potassium levels (mmol/L) from baseline.
Blood potassium (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood chloride levels (mmol/L) from baseline.
Blood chloride (mmol/L) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.
Change in blood glucose levels (mg/dL) from baseline.
Blood glucose (mg/dL) will be obtained at baseline and collected prior to each administration and 60 minutes post administration.
Time frame: Baseline through 48 weeks or end of treatment.